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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Masan Samsung Hospital, South Korea
Asan Medical Center
Inje University
Chonnam National University Hospital
Chung-Ang University
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01127100
First received: May 19, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

May 19, 2010
July 19, 2011
May 2010
December 2011   (final data collection date for primary outcome measure)
Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group [ Time Frame: Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64) ] [ Designated as safety issue: No ]
Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group.
Same as current
Complete list of historical versions of study NCT01127100 on ClinicalTrials.gov Archive Site
Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group [ Time Frame: Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64) ] [ Designated as safety issue: No ]
Post-treatment secondary efficacy assessments will be used to determine the percentage of difference and secondary efficacy assessments included the following. 1. Korean Oswestry Disability Index score, Korean-Short-Form 36, Beck Depression Index score, investigator and patients global assessment.
Same as current
Not Provided
Not Provided
 
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain
Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial

Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain.

The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Neuropathic Pain
  • Spinal Stenosis
Drug: transdermal fentanyl matrix, gabapentin

transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained.

Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained.
  • Experimental: Transdermal fentany matrix
    Transdermal fentanyl matrix is second-line medication on the neuropathic pain but gabapentin is the first-line medication. So, transdermal fentanyl matrix is experimental arm and gabapentin is active comparator arm.
    Intervention: Drug: transdermal fentanyl matrix, gabapentin
  • Active Comparator: gabapentin
    Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.
    Intervention: Drug: transdermal fentanyl matrix, gabapentin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
116
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients are 20 years of age or older
  • patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS)
  • neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change
  • positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment
  • patients who can make out the questionnaire
  • patients have agreed with the informed consent

Exclusion Criteria:

  • patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine)
  • patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc.
  • patients who have other disease which causes more pain compared with neuropathic pain
  • patients with a history of drug or alcohol abuse
  • patients who are pregnant or have the possibility of pregnancy
  • patients who are unable to use a transdermal system due to skin disease
  • patients with a serious mental disease
  • patients with a history of hypersensitivity to opioid analgesics
  • patients with a chronic pulmonary disease or respiratory depression
  • patients combined with industrial accidents or traffic accidents
  • at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01127100
Neuropathic pain 2010
No
Jin-Ho Cho, Seoul National University, College of Medicine, SMG-SNU Boramae Medical Center
Seoul National University Hospital
  • Seoul National University Bundang Hospital
  • Masan Samsung Hospital, South Korea
  • Asan Medical Center
  • Inje University
  • Chonnam National University Hospital
  • Chung-Ang University
Principal Investigator: Jae Hyup Lee, MD, PhD Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Seoul National University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP